1. Field of the Invention
This invention relates to methods and means for packaging surgical needles and sutures, and, more particularly, to protective packaging devices that may serve to facilitate manipulation and removal and to account for and dispose of surgical needles and sutures.
2. Description of the Prior Art
To reduce the time of operative procedures and to permit surgeons to utilize their skills more effectively, it has become increasingly common practice to package surgical tools and appliances in a manner in which they are most readily accessible to operating room personnel. In addition to using packaging techniques that permit the operating room nurse and the surgeon to manipulate the various surgical devices, the devices are packaged in a sterile environment so that the devices are immediately available for use as may be required. This simplifies older techniques in which the requirements of a given operative procedure have to be anticipated and the various tools and appliances that will be used are sterilized and made ready for use prior to the operation.
The packaging trend has advanced to the extent that entire kits are assembled containing all appliances and tools that will be needed for a given operative process. In many cases, it is more efficient and less expensive to include sterile disposable items in kit form than it is to clean and sterilize individual surgical devices for reuse. A primary advantage that is gained is that a surgeon is assured that all of his requirements for special tools and appliances will be readily available to him during an operation without advance preparation or running down a check list. A secondary advantage is that, since the contents of a kit are all readily identifiable, it is comparatively simple to account for all of the tools and appliances that have been used during an operation and reduce the possibility of leaving a device within the patient.
In keeping with the above thinking, it has become rather common practice to package and store surgical needles and sutures in sterile packages. These packages are designed to permit sterilizing the contents and maintaining the contents in a sterile condition until they are removed for use. In one well-recognized method for the sterile packaging of needles and sutures, the needle or suture is sealed within a protective envelope having at least one portion which is pervious to sterilizing gas, such as ethylene oxide, but which is impervious to the passage of bacteria. An example of these gas-pervious, bacteria-impervious materials is a spun bonded polyolefin material sold by DuPont under its trademark "Tyvek". To utilize this type of material, a surgical device, such as a needle or suture, is placed in an impervious tray or tub and a film of the gas-pervious, bacteria-impervious paper or plastic is sealed to flanged edges of the tray. The sealed package is then exposed to ethylene oxide which permeates the paper or plastic and sterilizes the contents of the package. Since the paper or plastic is designed to prevent the passage of bacteria, the contents of the package will remain sterile until the seal is broken.
Depending upon the preference of the surgeon and the type of wound to be closed, the needle may contain an eye for threading a surgical thread through the needle or, particularly in more delicate operations, the needle may be packaged as a suture with the surgical thread attached to the needle.
Sometimes a needle is affixed at each end of the surgical thread to provide a double-armed suture which allows a wound to be closed by using both ends of the surgical thread. These double-armed sutures are also convenient since they make two sutures readily available when the surgical thread is cut at any selected point between the two needles.
The techniques of enclosing and storing a needle or suture within a package that may be sterilized are well developed in the prior art and do not, in themselves, form a part of this invention. Rather, this invention is concerned with methods for mounting a suture on a holding device that, in addition to further advantages discussed below, will protect the point of the needle, will act as a holding device to permit manipulation of the suture, and will form a support on which the surgical thread is organized to avoid tangles, snags or permanent deformation, yet allow rapid removal of the suture without the need for manipulating the holder.
Numerous patents may be found in the prior art that adequately perform certain of these functions to varying degrees, but none of them do all of them well. Also, needle and suture packages employing sterile, nonsloughing foam materials as a holder are found in the prior art. In one such package, two eyed needles were carried on opposed side edges of a planar sheet of such foam material. The foam sheet was used to retain and protect the points and eyes of the needles during shipment and to hold the needles for threading by the surgeon. Also, strips of such materials have been used for packaging sutures, and particularly double-armed sutures. One such design comprises a sheet of foamed material having recessed portions on opposed edges adjacent one end of the sheet. Three retaining slits for retaining the surgical thread are located in the ends of the strip of foam. This design has the disadvantage that it requires undue manipulation of the package in order to remove a suture; the needle is grasped by the surgeon and the thread must then be unwound from the foam strip. The suture of usage length cannot readily be removed from the package by merely exerting an axial pull on the suture.